Accra-Pac, Inc.
FDA inspection history in Elkhart, Indiana, 2021 to 2026
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2021: one Form 483; 2022: one Form 483; 2023: one warning letter; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–23Two Form 483s and one warning letter, at Elkhart, Indiana.
- 2022The longest 483 on file: 5 observations over 7 pages at Elkhart, Indiana.
- 2026One Form 483, at Elkhart, Indiana.
Cited most
Across all Accra-Pac observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.105Equipment identification1
- 21 CFR 211.160General requirements1
- 21 CFR 211.182Equipment cleaning and use log1
- 21 CFR 211.192Production record review1
The complete Accra-Pac file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Elkhart, Indiana
Three Form 483s and one warning letter · 2021 to 2026 · 13 observations
Latest: Form 483, Mar 5, 2026 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-05 | 483 Form 483 | Elkhart, Indiana | 5 | $99 |
| 2023-04-20 | Warning letter Warning letter | Elkhart, Indiana | — | $99 |
| 2022-09-02 | 483 Form 483 | Elkhart, Indiana | 5 | $99 |
| 2021-11-05 | 483 Form 483 | Elkhart, Indiana | 3 | $99 |
Investigators on these documents
FEI number 1818911 · most recent document Mar 5, 2026
About Accra-Pac, Inc.
How many FDA Form 483s has Accra-Pac, Inc. received?
FDA Intel has 3 Form 483s on file for Accra-Pac, Inc.; the most recent is dated Mar 5, 2026.
When was Accra-Pac, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Accra-Pac, Inc. is a Form 483 dated Mar 5, 2026, for the site in Elkhart, Indiana.
What did FDA cite at Accra-Pac, Inc.?
The regulations cited most in the observations on file for Accra-Pac, Inc. are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.105 (Equipment identification), 1 time; 21 CFR 211.160 (General requirements), 1 time.
Has Accra-Pac, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Accra-Pac, Inc.; the most recent is dated Apr 20, 2023.